Tests GXV813 in hospitalized adults with schizophrenia
Tests GXV813 against placebo in hospitalized adults with an acute schizophrenia episode.
Plain-language title generated from the registry record
Registry title: Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia
Key facts
- Where
- Haskovo, Kazanlak, Lovech, Plovdiv, Sliven, Sofia, Veliko Tarnovo, and Vratsa, BulgariaSee the 8 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07467993, who can take part
Where in Bulgaria
- HaskovoHaskovo, BulgariaTaking people
- KazanlakKazanlak, BulgariaTaking people
- LovechLovech, BulgariaTaking people
- PlovdivPlovdiv, BulgariaTaking people
- SlivenSliven, BulgariaTaking people
- SofiaSofia, BulgariaTaking people
- Veliko TarnovoVeliko Tarnovo, BulgariaTaking people
- VratsaVratsa, BulgariaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07467993
- Record updated
- 29 July 2026
- Original description
The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophreniaRead full original descriptionShow less
A Phase 2a, Randomized, Participant- and Investigator- Blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With DSM-5 Schizophrenia (STAR-1)
The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia
Inclusion: Participant is aged 18 to 65 years, inclusive, at screening; Participant is capable of providing informed consent; Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT); Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements; Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening; The participant requires hospitalization for this acute exacerbation or relapse of symptoms; If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening; Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening a. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items:; Item 1 (P1; delusions); Item 2 (P2; conceptual disorganization); Item 3 (P3; hallucinatory behavior); Item 6 (P6; suspiciousness/persecution).
Exclusion: Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) at screening); History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia; Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded; Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA TRINZA®) before baseline; Other protocol-defined inclusion/exclusion criteria may apply.